Manager QA and Compliance

Key Duties & Responsibilities

QMS section:

1. Work as a final approver for all quality and cross functional documents like but not

limited to SOP, Formats, Batch records, Analytical records like Specification, Method

of analysis etc.

2. To act as a final approver for different Quality and Service agreements with

customers, vendors and service providers and to ensure the adherence of the same

during routine operation and execution.

3. To ensure all the team members are executing the task and works within the defined

job roles in day to day routine quality operations activity.

4. Primarily responsible for assurance of quality matrix of the Ahmedabad site by

assuring the quality management system like Management of Change controls,

Management of Market complaint, Deviation Management, OOS management are

been done per the define process work flow.

5. Primary responsible for managing and handling audits (Internal, Customer,

Regulatory and Certification Body).

6. Management of all CAPA for internal and external audit, including CAPA taken

against any investigation with tracking, effectiveness verification and closure.Page 2 of 3

7. To ensure Quality Matrix Monthly/Quarterly/Half yearly and Annual, preparation and

compilation.

8. To ensure monthly trend preparation of complaint per the procedure.

9. Management and procedural execution of Management review meeting.

10. To be responsible for batch release of finished products.

11. Responsible for ISO, NABL, FSSC2200, EXCiPACT training and certification

12. To lead product permission activity with State FDA and CAA wherever applicable.

13. Responsible for Vendor audit for RM and PM and New PM vendor development

process

14. To ensure operational support to production, packing and engineering teams.

15. Responsible for contract manufacturing quality and process oversite wherever

applicable.

16. Marketing request handling and resolution for queries received from diff customer or

regulatory bodies.

17. Management of all quality system documents but not limited to SMF, IMS , VMP ect.

18. To act as an administrator and executor whichever is applicable for allocated

computer systems used in GMP operations like Mastercontrol Software.

19. Responsible for complete stability management program for the applicable product

grades.

20. To ensure the development of new product and launches per the required business

flow, grade and regulatory and customer compliance.

Education

B.Pharma/M.Pharma, Msc. Chemistry, B tech or M tech with biotechnology or chemistry.

Experience

12-13 years of experience in Pharmaceutical, API or excipient regulated industries.

Competencies & Skillsets

Functional / Technical

Behavioral

1. Technical knowledge of

API/Excipient/Pharma manufacturing and

packaging with technical writing skills

2. Indepth knowledge of Document and

data management, Quality Management

System, Investigation tools and RCA

tools knowledge and implementation.

3. Audit handling and auditing skills

4. SOP writing and review skills

5. Training and management skills

6. GMP regulatory guidance knowledge

and implementation skills.

1.

able to lead the team

strategically.

2. Critical Thinking - Objective

analysis and evaluation in

order to form judgement.

3. Result Orientation -

Accountability and meeting

organizational objectives.

4. Problem Solving - A knack to

solve problem with an

objective approach.

5. Effective communication and

counseling skill